Tybost generics — when can they launch?
Tybost (COBICISTAT) · Gilead Sciences · 54 active US patents · 0 expired
Where Tybost sits in the generic timeline
All listed Orange Book patents for Tybost have expired. Generic entry is permitted, and ANDA filers can launch without patent infringement risk. Hatch-Waxman exclusivity (NCE/ODE/PED) may still apply if recently approved.
Under US Hatch-Waxman, a generic enters via an ANDA (Abbreviated New Drug Application) and may file with one of four Paragraph IV certifications attacking the brand's listed patents. If the brand sues within 45 days, a 30-month FDA approval stay is triggered. First Para IV filer typically gets 180-day market exclusivity.
Patent estate by type — active patents
Method-of-use patents only carve out specific indications; generics can launch with a "skinny label" omitting those uses. Composition-of-matter patents block the molecule itself.
- Other — 22 patents
- Method of Use — 20 patents
- Formulation — 7 patents
- Composition of Matter — 5 patents
FDA U-codes carved out by Tybost patents
Method-of-use patents are listed against specific FDA Patent Use Codes ("U-codes") representing carved-out indications. Generics can launch with a label that omits these uses.
| U-code | Description |
|---|---|
U-257 | (no description) |
U-2353 | (no description) |
U-1279 | (no description) |
U-4162 | (no description) |
U-2352 | (no description) |
U-2978 | (no description) |
Sample patent estate
Showing 6 of 54 active US patents. View full estate on the Tybost drug page →
-
This patent protects a 4-oxoquinoline compound used as an anti-HIV agent with HIV integrase inhibitory action.USPTO title: 4-oxoquinoline compound and use thereof as pharmaceutical agent
-
This patent protects a 4-oxoquinoline compound used as an anti-HIV agent with HIV integrase inhibitory action.USPTO title: 4-oxoquinoline compound and use thereof as pharmaceutical agent
-
This patent protects a stabilized crystal of a specific compound used in the drug Tybost.USPTO title: Stable crystal of 4-oxoquinoline compound
-
This patent protects a stabilized crystal of a specific compound used in the drug Tybost.USPTO title: Stable crystal of 4-oxoquinoline compound
-
This patent protects a stable crystal form of the compound 6-(3-chloro-2-fluorobenzyl)-1-[(S)-1-hydroxymethyl-2-methylpropyl]-7-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid.USPTO title: Stable crystal of 4-oxoquinoline compound
-
This patent protects a stable crystal form of the compound 6-(3-chloro-2-fluorobenzyl)-1-[(S)-1-hydroxymethyl-2-methylpropyl]-7-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic acid.USPTO title: Stable crystal of 4-oxoquinoline compound
Sources
- FDA Orange Book — patents listed against Tybost (NDA filed 2012)
- Tybost drug profile — full patent estate, indications, clinical trials, pricing
- Gilead Sciences patent portfolio
- Patent cliff 2026 — every drug losing US exclusivity that year
Patent term extensions (PTR, pediatric exclusivity), Hatch-Waxman 30-month stays, and FDA regulatory exclusivity (NCE/ODE/PED) may shift the effective generic entry date. Not legal advice.
Get generic entry alerts
Free Pharma CI alerts on Tybost — get notified the moment an ANDA Paragraph IV certification is filed, a 30-month stay is triggered, or a generic launches. First 2 drugs free.
Subscribe free →